Drug Use Investigation Of Varenicline (Regulatory Post Marketing Commitment Plan)

Drug Use Investigation Of Champix (Regulatory Post Marketing Commitment Plan)

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: Varenicline

Detailed Description

All the patients whom an investigator prescribes the first Varenicline(Champix) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

• Study Type: Observational
• Enrollment (Actual): 3939

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The patients whom an investigator involving A3051109 prescribes the Varenicline(Champix).

Description

Inclusion Criteria:

• Patients need to be administered Varenicline(Champix) in order to be enrolled in the surveillance.

Exclusion Criteria:

• Patients not administered Varenicline(Champix).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Varenicline; Patients taking Varenicline.

Drug: Varenicline; Champix Tablets 0.5mg or Champix Tablets 1mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage for oral use is 0.5 mg of varenicline once daily after eating for days 1 to 3, 0.5 mg twice daily after eating in the morning and evening for days 4 to 7, and 1 mg twice daily after eating in the morning and evening on and after day 8. The drug should be administered to patients for 12 weeks."; Other Names: Champix, Chantix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk Factors for the Frequency of Treatment Related Adverse Events - Gender.	Number of participants with Treatment Related Adverse Events of Varenicline to determine whether gender is a significant risk factor.	24 weeks
Risk Factors for the Frequency of Treatment Related Adverse Events - Age.	Number of participants with Treatment Related Adverse Events of Varenicline to determine whether age is a significant risk factor.	24 weeks
Risk Factors for the Frequency of Treatment Related Adverse Events - Chronic Obstructive Pulmonary Disease as a Complication.	Number of participants with Treatment Related Adverse Events of Varenicline to determine whether Chronic obstructive pulmonary disease as a complication is a significant risk factor.	24 weeks
Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Drugs.	Number of participants with Treatment Related Adverse Events of Varenicline to determine whether taking concomitant drugs is a significant risk factor.	24 weeks
Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Therapies.	Number of participants with Treatment Related Adverse Events of Varenicline to determine whether receiving concomitant therapies is a significant risk factor.	24 weeks
Risk Factors for the Frequency of Treatment Related Adverse Events - Weight at Baseline.	Number of participants with Treatment Related Adverse Events to determine whether weight at baseline is a significant risk factor.	24 weeks
Risk Factors for the Proportion of Responders - Tobacco Consumption Per Day.	The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.	24 weeks
Risk Factors for the Proportion of Responders - Prolonged Administration After 12 Weeks.	The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.	24 weeks
Risk Factors for the Proportion of Responders - Antipsychotics as a Concomitant Drug.	The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.	24 weeks
Number of Participants With Treatment Related Adverse Events.	Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Varenicline. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.	24 weeks
Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.	Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Numbers of Treatment Related Adverse Events were evaluated in company with the causal relationship to Varenicline. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Continuous Abstinence Situation by 52 Weeks.	Number of participants with dependence on Varenicline by 52 weeks. Varenicline-dependent Treatment Related Adverse Events are Feeling abnormal, Feeling drunk, Feeling jittery, Disturbance in attention, Dizziness, Memory impairment, Mental impairment, Psychomotor hyperactivity, Sedation, Somnolence, Confusional state, Depersonalisation, Disorientation, Dissociation, Euphoric mood, Mood variable, Mood swings, and Hallucination.	52 weeks

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: October 13, 2008
• First Submitted That Met QC Criteria: October 13, 2008
• First Posted (Estimate): October 15, 2008

Study Record Updates

• Last Update Posted (Estimate): February 28, 2014
• Last Update Submitted That Met QC Criteria: January 28, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: A3051109